Sienna+® Injection Time Study 4 Arms

Breast Neoplasms Clinical Trial

— Sentimag02  

Official title:

Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02612870
• Other study ID #: Baden201512
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 18, 2015
• Last updated: November 23, 2015
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Kantonsspital Baden
• Contact: Nik Hauser, PD Dr.
• Phone: +41 56 486 36 36
• Email: brustzentrum[@]ksb.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

Description:

Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally:

• Sienna+® retro-mamillary 1 day before surgery: 10 patients

• Sienna+® peri-tumorally 1 day before surgery: 10 patients

• Sienna+® retro-mamillary 4-6 days before surgery: 10 patients

• Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, Technetium as standard technique is employed according to the gold standard protocol one day before surgery.

The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject has a diagnosis of primary breast cancer

• Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure

• Subject is =18 years old at time of consent

• Subject has an ECOG performance status of Grade 0-2

• Subject has a clinical negative node status

• Subject is available for the follow-up

Exclusion Criteria:

• Subject is pregnant or lactating

• Subject has a radiological evidence of metastatic cancer

• Subject has had previous axilla surgery or reduction mammoplasty

• Subject has impaired lymphatic function

• Subject has had a preoperative radiation therapy

• Subject has iron overload disease or iron/dextran intolerance

• Subject has a pacemaker

• Subject is under guardianship

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• Sienna+ retro
Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
• Sienna+ peri
Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
• Sienna+ retro 4-6
Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
• Sienna+ peri 4-6
Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
• Technetium 1
Sentinel node marking with Technetium 1 day before surgery

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden
Switzerland	Inselspital Bern, Universitätsklinik für Frauen.	Berne

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Baden	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magn — View Citation

Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Eng — View Citation

Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan — View Citation

Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate per Patient	Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.	During surgery	No
Secondary	Number of lymph nodes excised	Number of excised sentinel lymph nodes	During surgery	No
Secondary	Nodal detection rate	Number of detected versus excised sentinel lymph nodes with either method.	During surgery	No
Secondary	Malignancy rate	Number of histologically confirmed malignant sentinel lymph nodes detected with either method.	1-2 days post surgery	No